Gluten-Free Labeling of Food Products Expermental Study

Forms and Documents

Document Name	Status
Gluten Addendum.doc Supplementary Document	2010-02-19
GF SS Part B- Rev 2-19-10.doc Supporting Statement B	2010-02-19
GF SS Part A (REV2-19-10).doc Supporting Statement A	2010-02-19

IC Document Collections

IC ID	Document Title	Status
191594	Draft Online Questionnare With Convenience Sample Other-Questionnaire	New
191593	Draft Online Panel Questionnaire Other-Alpine Krunch Screenshot	New
191592	Draft Paper Questionnaire Other-Questionnaire	New
191591	Online Pre-Test Other-Pre Test	New
191590	Telephone Paticipant Screener Other-Screener	New
191589	Online Participant Screener Other-Screener	New

ICR Details

OMB Control No: 0910-0656	ICR Reference No: 200912-0910-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Gluten-Free Labeling of Food Products Expermental Study
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/21/2010
	Date Received in OIRA: 12/16/2009
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years. However, should the agency changes the survey instrument as outlined in the supplementary document "Gluten Addendum," they must submit the final draft for OMB approval prior to conducting the survey. They may submit their request for approval as a "non-substantive" change.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2013	36 Months From Approved
Responses	17,140	0	0
Time Burden (Hours)	2,015	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Under section 903b of the Federal food Drug and Cosmetic Act (the act),(21 U.S.C.393 (b)(2), FDA is authorized to conduct research relating to foods and to conduct educational and public information programs relating to the safety of the nations food supply. The 'Gluten - Free Labeling of Food Products Experimental study" will collect infomationfrom both consumers who have celiac disease or gluten intolerance and those who do not have either condition. The purpose of the study is to guage perceptions of characteristics related to claims of "gluten free." Further, the results of this study will be used to help FDA define how gluten-free terms can be used on food product labels.

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Authorizing Statute(s): US Code: 21 USC 393(b)(2) Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 9822	06/06/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 59188	11/17/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Online Participant Screener
Draft Paper Questionnaire
Draft Online Panel Questionnaire	FDA	Electronic Gluten Experiment
Draft Online Questionnare With Convenience Sample
Telephone Paticipant Screener
Online Pre-Test

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	17,140	0	0	17,140	0	0
Annual Time Burden (Hours)	2,015	0	0	2,015	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection of infomation

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Annual Cost to Federal Government: $159,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 12/16/2009

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